FDA undertakes TNF study

6/4/2008

WASHINGTON The Food and Drug Administration is conducting a safety review of tumor necrosis factor blockers, which include the drugs Enbrel manufactured by Amgen and Wyeth, Abbott Laboratories’ Humira, UCB’s Cimzia and Centocor’s Remicade.

The drugs are being reviewed for a possible association between their use and the development of lymphoma and other cancers in children and young adults treated with the drugs for juvenile idiopathic arthritis and Crohn’s disease. The drugs suppress the immune system by blocking the activity of TNF, a substance in the body that can cause inflammation and lead to immune system-related diseases such as JIA, and Crohn’s disease.

The agency has asked the makers of the TNF blockers approved for use in children and young adults) to supply information about all cases of cancer reported in children and young adults taking TNF blockers.

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